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Incretin-based drugs and intestinal obstruction: A pharmacovigilance study
- Source :
- Thérapie, Thérapie, EDP Sciences-Depuis 2016, la revue Thérapie n’est plus publiée par EDP Sciences.> Therapies (Elsevier), 2020, 75 (6), pp.641-647. ⟨10.1016/j.therap.2020.02.024⟩, Thérapie, EDP Sciences, 2020, 75, pp.641-647. ⟨10.1016/j.therap.2020.02.024⟩
- Publication Year :
- 2020
- Publisher :
- HAL CCSD, 2020.
-
Abstract
- Summary Aims To investigate the risk of intestinal obstruction associated with incretin-based drugs by performing a disproportionality analysis of adverse reaction reports in a global pharmacovigilance database. Methods We conducted a case/non-case analysis using VigiBase, the World Health Organization's adverse drug reactions (ADR) database, to assess intestinal obstruction reporting associated with incretin-based drugs (glucagon-like peptide 1 analogues [GLP-1a] and dipeptidyl peptidase 4 inhibitors [DPP-4i]. Cases were defined as reports of gastrointestinal stenosis and obstruction (MedDRA High Level Group Term) and non-cases were all other reactions recorded. Disproportionality analysis were performed by computing reporting odds ratios (ROR) with their 95% confidence interval (95%CI) within all ADR reports concerning diabetes drugs from January 2007 to January 2018 and in a restricted sample including only serious reports. Results A total of 501,244 ADR with diabetes drugs were reported in VigiBase during the study period. We identified 452 intestinal obstructions involving an incretin-based drug. In disproportionality analyses, intestinal obstructions were more than 4.5 times more frequently reported with incretin-based drugs than with other diabetes drugs (ROR 4.52, 95% CI: 3.87–5.28) with a higher signal for serious cases and for DPP-4i (ROR 8.66, 95% CI: 7.27–10.32) compared to GLP-1a (ROR 3.05, 95% CI: 2.54–3.66). Conclusions We identified a pharmacovigilance signal that suggests a risk of potentially serious intestinal obstruction associated with incretin-based drugs, as a class and with a greater signal for DPP4-i. Other studies are needed to confirm and better understand the potential risk of intestinal obstruction associated with incretin-based drugs.
- Subjects :
- Drug
medicine.medical_specialty
Databases, Factual
media_common.quotation_subject
MedDRA
[SDV]Life Sciences [q-bio]
Adverse drug reaction
Incretin
030226 pharmacology & pharmacy
Incretins
03 medical and health sciences
Pharmacovigilance
0302 clinical medicine
Ileus
Diabetes mellitus
Internal medicine
medicine
Adverse Drug Reaction Reporting Systems
Humans
Pharmacology (medical)
Adverse effect
Incretin-based drugs
media_common
Dipeptidyl-Peptidase IV Inhibitors
business.industry
Odds ratio
medicine.disease
3. Good health
[SDV] Life Sciences [q-bio]
Pharmaceutical Preparations
Intestinal obstruction
business
Subjects
Details
- Language :
- English
- ISSN :
- 19585578 and 00405957
- Database :
- OpenAIRE
- Journal :
- Thérapie, Thérapie, EDP Sciences-Depuis 2016, la revue Thérapie n’est plus publiée par EDP Sciences.> Therapies (Elsevier), 2020, 75 (6), pp.641-647. ⟨10.1016/j.therap.2020.02.024⟩, Thérapie, EDP Sciences, 2020, 75, pp.641-647. ⟨10.1016/j.therap.2020.02.024⟩
- Accession number :
- edsair.doi.dedup.....b2052c4efa822d6db7a0bc8509c88a08